Evaluation of a playful VR intervention for children and their caregivers to reduce pain, anxiety, and stress during painful procedures
Not Applicable
Recruiting
- Conditions
- Port puncturingLumbar puncturePeripheral/central venous catheter insertionKirschner-wire removal
- Registration Number
- DRKS00033544
- Lead Sponsor
- niversitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
Procedure possible without sedation
- Sufficient knowledge of the German language by patient and carergiver
Exclusion Criteria
- Visual impairments (e.g., stereo vision disorders, color blindness, severe defective vision)
- Severe cognitive impairments
- Epilepsy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective pain, anxiety, and stress experience of the patient measured with STAIK (State-Trait-Anxiety Inventory for Children), VAS Anxiety and VAS Pain (Visual Analog Scale), and PANAS-K (Positive Affect Negative Affect Schedule for Children) . Measurement directly before the procedure (pre) and directly after the procedure (post).
- Secondary Outcome Measures
Name Time Method Subjective anxiety and stress experience of the caregiver, measured with STAI (State-Trait-Anxiety Inventory) and PANAS (Positive Affect Negative Affect Schedule). Measurement directly before (pre) and after (post) the procedure.<br><br>Player experience of patient and caregiver, measured with PXI (Player Experience Inventory), directly after the procedure (post)<br><br>Patient experience (i.e. feelings during the procedure) with self-formulated items after (post) the procedure.<br><br>Interviewer assessment of the procedure, the patient's emotional experience, and cooperativeness as well as the gameplay using observation protocol with self-formulated items, VAS anxiety/pain and CHEOPS (Children's Hospital of Eastern Ontario Pain Scale). Measurement during the procedure.